CROSSLIFE TECHNOLOGIES INC. — Department of Health and Human Services SBIR Phase I: NCI

Description

We propose the development of a highly sensitivesimple paper strip molecular nucleic acid test that detects the liver fluke Opisthorchis viverrini and Clonorchis sinensis at the point of care using a platform technology called TARAampTemplate Assisted Rapid AmplificationThe final product to be developed in Phaseis an FDA approved nucleic acid based diagnostic device paper dipstick test that contains a multiplex of probe that can amplify and detect nucleic acid sequences from the Opisthorchis viverrini and Clonorchis sinensis directly from CLBuffer stabilized blood without RNA extractionThe target sequences are amplified using the TARAamp technology which is composed of a template dependent chemical ligation reaction with high turnoverand gold nanoparticlesGNPdetection and lateral flow readoutThe test is rapidand results in the appearance of colored bands that are detectable by eye or phone ReaderThe test can detect LOD is ltcopies of DNA per testIn Phasewe will conduct a large scale validation experiment to obtain expedited review approval and recommendation for procurement of our product from the WHOIn Phasewe will develop a CrossLife mobile readercollaboration with NovarumDxfor our developed test cassette that will provide the user with unambiguous resultsby removing any subjectivityOur simple to use technology may be supplemented with test choreographythat aids to reduce error rates in the system even furtherand is particularly important for less trained healthcare workers